It is understood that most medical reagents, biological agents and pharmaceuticals are subject to deterioration due to changes in the temperature of the proteins contained in the environment, requiring more stringent temperature control. Therefore, it is extremely urgent to strengthen the safety monitoring of vaccines, drugs and reagents in the circulation basin.
Medical cold chain storage and transportation equipment is an indispensable important position in the safety management of cold chain.
In recent years, vaccine and drug safety incidents have occurred frequently, and the medical cold chain has been mentioned more and more frequently. With the continuous improvement of people's living standards and health needs, the safety awareness of food and medicine has been significantly enhanced in the whole society. Play an increasingly important role in people's lives.
According to the monitoring data of relevant departments, the coverage capacity of China's pharmaceutical cold chain is about 10%, and nearly 20% of the drug quality problems are related to the cold chain. The temperature exceeding the standard in the circulation of frozen drugs will seriously threaten the quality of drugs and patient safety. It is caused by improper control of process temperature such as drug storage or transportation. It can be seen that cold chain management plays an important role in drug safety management.
It is understood that most medical reagents, biological agents and pharmaceuticals are subject to deterioration due to changes in the temperature of the proteins contained in the environment, requiring more stringent temperature control. Biological agents such as vaccines, cytokines, enzyme preparations, and blood products are very sensitive to temperature. For example, in the temperature range of 2~8 °C, the storage, transportation, transfer, and distribution processes are required to be maintained under the specified refrigerated state and effective time. The quality is stable, otherwise it is prone to degeneration, degradation, aggregation and loss of biological efficacy, and may also release harmful components such as sensitizing factors, posing a threat to clinical use. Specific drug temperature control conditions can be divided into four categories:
(1) Refrigerated medicine, the temperature requirement is 2~8 °C;
(2) cooling the drug, the temperature requirement is 8~15 °C;
(3) frozen drugs, the temperature requirement is -10 ~ -25 ° C (the temperature usually required for the vaccine);
(4) Deep frozen chain drugs, the temperature requirement is -70 ° C, these drugs are basically the stock solution of cold chain drugs, such as Herceptin is stored at 2 ~ 8 ° C, but its stock solution is stored in -70 ° C environment .
It can be seen that the safety of the medical cold chain is closely related to people's lives, involving multiple links, from factories to distribution centers, from distribution centers to provincial customers or regional secondary distribution centers, from provincial customers to municipal customers to county level. Customers, ultimately to the user, need to refrigerate storage at each link, also need cold chain transportation, need refrigeration equipment and equipment, need refrigerated trucks and vaccine transport, but the end customer cold chain drug transport is small, refrigerated truck transport is often not Economy, the need to move refrigerators, refrigerators, freezers and other professional low-temperature storage equipment.
I believe that many domestic cold chain equipment suppliers are deeply touched by illegal food, medicine and vaccine incidents. Therefore, it is urgent to strengthen the safety monitoring of vaccines, drugs and reagents in the circulation basin. The national food and drug supervision and local food and drug supervision are to increase the management of cold chain storage and transportation of medicines, and continuously improve the coverage of medicines and vaccines and ensure the cold chain coverage. It is stored in a safe temperature environment in every circulation, ensuring that the entire cold chain is not broken.
